503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility under Section 503B of the Federal Food, Drug, and Cosmetic Act. This designation signifies a commitment to the highest standards of quality, safety, and compliance in pharmaceutical compounding. Located at 2160 W State Road 434, Longwood, FL 32779, this facility provides a critical service by producing compounded medications that are not commercially available, thereby addressing specific patient needs that mass-produced drugs cannot meet. The operations at this location are distinct from traditional compounding pharmacies, as an outsourcing facility is subject to rigorous federal oversight, including current Good Manufacturing Practice (cGMP) regulations. This ensures that every preparation leaving the facility meets stringent quality control benchmarks for potency, purity, and sterility.
The core function of 503B Compounding Pharmacy at 2160 W State Road 434 is the large-scale compounding of medications for office use. This model allows healthcare providers in the local medical community to obtain essential medications for their practice without the need to engage in compounding themselves. Physicians, surgeons, and other medical professionals can confidently utilize these preparations for in-office procedures, ensuring their patients receive consistent, high-quality care. The facility's production capabilities are designed to support the demands of the healthcare ecosystem, providing a reliable and compliant source for sterile and non-sterile compounded preparations.
By focusing on the specific needs of practitioners, 503B Compounding Pharmacy enhances patient care pathways. The availability of office-use medications means that treatments can be administered promptly during patient visits, improving convenience and adherence. The facility at 2160 W State Road 434, Longwood, FL 32779, is equipped to handle a significant volume of orders while maintaining the personalized attention to detail required in pharmaceutical compounding. This operational scale, governed by federal quality standards, provides a level of assurance for both prescribers and patients regarding the medications' safety and efficacy.
Engagement with the 503B outsourcing facility is facilitated through direct communication with healthcare providers and their offices. The process is designed to be seamless, allowing for efficient ordering and fulfillment of necessary compounded preparations. For more information on available preparations or to initiate an order, healthcare providers can contact the facility directly. The team at 503B Compounding Pharmacy is dedicated to supporting the local medical community from its location at 2160 W State Road 434, Longwood, FL 32779.
Contact Information:
Website:
Phone: (407)993-1381
Frequently Asked Questions:
1. What does it mean that this is a 503B outsourcing facility?
Being a 503B outsourcing facility means our operations at 2160 W State Road 434 are registered with the FDA and we compound medications in accordance with federal current Good Manufacturing Practice (cGMP) regulations. This ensures a higher level of regulatory oversight and quality control compared to a traditional pharmacy.
2. Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434 are designed for healthcare providers, including physicians, surgeons, and other qualified medical professionals, for office use. We provide medications that practitioners can administer to patients within their practice setting.
3. Can individual patients pick up prescriptions directly from your location?
No. As a 503B outsourcing facility, our primary function is to supply medications for office use to healthcare providers. Individual patient prescriptions are typically handled by traditional compounding pharmacies, not by this facility at 2160 W State Road 434.
4. What types of medications does the facility compound?
503B Compounding Pharmacy at this location compounds a range of sterile and non-sterile preparations intended for office use. The specific available preparations can be discussed directly with healthcare providers who are establishing an account with our facility.
5. How does a healthcare provider place an order?
Healthcare providers interested in our services can contact our facility directly at (407)993-1381 to discuss their needs, establish an account, and place orders for compounded preparations for use at their practice.